Intention-to-Treat

Intention-to-treat is a necessary component for any randomized controlled trial

"Intention-to-treat" analysis is a necessary part of any randomized controlled trial. "Intention-to-treat" is so important that when one is reading a randomized controlled trial and the methods do not state that study participants were analyzed in an "intention-to-treat" fashion, the trial should be immediately discarded.

"Intention-to-treat" means that all study participants are analyzed in the same groups to which they were randomly assigned to at the beginning of a study, REGARDLESS of falling out of the study early or loss to follow-up. All analyses associated with a randomized controlled trial should be conducted in an "intention-to-treat" fashion.

"Intention-to-treat" is important in randomized controlled trials. Remember, a randomized controlled trial is an experimental design that can produce causal effects between treatment regimens and clinical outcomes. If a treatment is being tested and 20% of the treatment group drops out of the study or is lost to follow-up, then only 80% of the population is represented in the statistical analysis. The ENTIRE point of using random selection and random assignment in experimental designs is to account for selection bias and have the most representative sample of individuals from which to make inferences. If 20% are not analyzed, then BY DEFAULT, the study results are not generalizable.

The "intention-to-treat" principle keeps researchers honest and statistical results yielded from randomized controlled trials valid and generalizable. Regardless of the fact that study participants fall out of a study or are lost to follow-up, they are still statistically analyzed as if they completed the study. If these members of a randomized controlled trial are not included in the final statistical analysis, then treatments effects could be falsely interpreted as either efficacious or deleterious.

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